Acute gingivitis, plaque induced
Conditions
Interventions
This study was designed as a double-blind, parallel-arm, randomized clinical trial to evaluate the safety and efficacy of a dual zinc plus arginine (DZA) and cetylpyridinium chloride with zinc lactate
Sponsors
Universidade de São Paulo
Colgate-Palmolive
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: men and women, between 18 and 65 years of age; availability to participate in the study; good general health (absence of any condition that, in the opinion of the principal investigator, could pose a risk to the subject during study participation. Examples include heart problems, valve/hip replacement, etc.); availability to provide information relating to your medical history; minimum of 15 permanent natural teeth (excluding third molars and teeth with crowns); diagnosis of moderate gingivitis (an initial gingival index score of at least 1.5); at least 10% of sites with bleeding on probing;
Exclusion criteria
Exclusion criteria: presence of any oral pathology or chronic disease that, in the opinion of the main investigator, may constitute a risk for the subject during participation in the study or may modify the progression and/or response to periodontal treatment; daily use of anticonvulsants, antihistamines, sedatives, tranquilizers, anti-inflammatory medication, or analgesics in the month prior to starting the study or scheduled to start using these medications during the course of the study; participation in another clinical trial; pregnancy or lactation; allergy to oral care products to be tested in the study; prolonged use of antibiotics or mouthwashes during the three months prior to the beginning of the study; need for antibiotic prophylaxis; continued use of medications known to affect gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine); periodontal treatment 12 months before the beginning of the study; more than two periodontal pockets (excluding pseudopockets) with bleeding on probing; smoking, history of alcohol abuse and/or drug use; existing medical condition that prohibits the individual from abstaining from eating or drinking for periods of up to 4 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1. Reduction in the gingival severity index (GSI) after 6 months of treatment. Based on the gingival index data, it is expected to observe a reduction in the gingival severity index (GSI) through clinical examination from the verification of a variation of at least 15% between the groups in the measurements before and after the intervention.;Outcome found 1: Gingival Severity Index (GSI) presented a difference of 37.5% between groups after 6 months of treatment, with a significant reduction in the test group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome found 5. Reduction in Interproximal Plaque Index (IPI) after 6 months of treatment presented a difference of 8.2% between groups after 6 months of treatment, with a significant reduction in the test group.;Expected outcome 2. Reduction in the Loe and Silness Gingival Index (GI) after 6 months of treatment. It is expected to observe a reduction in Loe and Silness Gingival Index (GI) through clinical examination from the verification of a variation of at least 15% between the groups in the measurements before and after the intervention.;Outcome found 2. Reduction in the Gingival Index (GI) index after 6 months of treatment. Gingival index (GI) showed a difference of 12.7% between groups after 6 months of treatment, with a significant reduction in the test group.;Expected outcome 3. Reduction in GingivaI Interproximal Index (GI) after 6 months of treatment. It is expected to observe a reduction in the GingivaI Interproximal Index (GI) through clinical examination from the verification of a variation of at least 15% between the groups in the measurements before and after the intervention.;Outcome found 3. Reduction in the interproximal Gingival Index (GI) index after 6 months of treatment presented a difference of 13.7% between groups after 6 months of treatment, with a significant reduction in the test group.;Expected outcome 4. Reduction in the Plaque Index (PI) after 6 months of treatment. It is expected to observe a reduction in the Plaque Index (PI) through clinical examination from the observation of a variation of at least 15% between the groups in measurements before and after the intervention.;Outcome found 4. Reduction in the Plaque Index (PI) after 6 months of treatment presented a difference of 7.3% between groups after 6 months of treatment, with a significant reduction in the test group.;Expected outcome 5. Reduction in the Interproximal Plaque Index (IPI) after 6 months of treatment. It is expected to observe a reduction in the Interproximal P | — |
Countries
Brazil
Contacts
Public ContactGiuseppe Romito
Universidade de São Paulo
Outcome results
None listed